Biological grafts and synthetic mesh are used to repair anatomical defects, such as hernias. Delivery of the mesh or graft into body cavities either requires invasive surgery, or heretofore unsatisfactory laparoscopic methods.
Hernias are structural defects most commonly involving the musculofascial tissues of the abdominal and pelvic regions within the human body. Some hernias involve internal muscular defects (i.e., diaphragmatic, hiatal hernias) while most involve the abdominal wall. Common types of abdominal wall hernias include inguinal, femoral, umbilical, ventral and incisional hernias. Unless they are completely without associated symptoms, most hernias eventually require surgical repair. Some of the common hernia symptoms include activity-induced pain, uncomfortable visible bulges, alteration in bowel function, and incarcerated or strangulated internal organs within the hernia resulting in emergent surgical intervention.
It is estimated that approximately 800,000 to 900,000 hernia operations are performed annually in the United States of which 200,000 involve ventral variety. Ventral hernias may be primary hernias (i.e., epigastric, Spiegelian hernias) but most commonly are incisional types which sometimes form after surgical incisions are made through the abdominal wall for the purpose of gaining access into the internal organs for various operations.
Surgical repair of ventral incisional hernias may be accomplished via an “open method.” This method involves making a sizable incision directly over the tissue defect, separating the contents of the hernia away from the musculofascial defect, and repairing the defect primarily using sutures, or more commonly, sewing a graft to the defect edge in tension-free manner. This is done in an effort to minimize the recurrence of hernia formation which, unfortunately, occurs with some frequency. The recurrence may be due to multiple factors including general health of the patient, surgical technique, and types of mesh or graft utilized. Overall, this traditional method is effective, but also often involves more pain, longer periods of disability following the surgery, higher perioperative infection rates, and an established hernia recurrence rate.
Alternatively, ventral incisional hernias may be repaired using the “laparoscopic method.” This method utilizes endoscopic or laparoscopic approach in which multiple tiny incisions are made remote from the musculofascial defect, trocars placed through these small incisions for access to the internal abdomen, internal organs or tissues separated from the hernia defect, a mesh or graft delivered through the trocar in some fashion, mesh or graft positioned over the defect and finally, graft or mesh secured around the defect with sutures and/or various fixation devices. This method is advantageous over the “open method” due to lesser surgical pain, shorter period of disability following surgery, lower infection rate and perhaps lower hernia recurrence rate. However, these perceived benefits are subject to vigorous debate within the surgical community.
Currently, approximately 30 to 40 percent of ventral incisional hernias are repaired using the laparoscopic method. However, this method has its own set of major shortcomings principally related to higher degree of difficulty in performing this procedure. One of the major challenges involve graft introduction into the abdominal cavity. Typically, a graft is rolled tightly into a cylindrical configuration and subsequently, pushed/pulled through the trocar which can be both time consuming and frustrating, especially when a larger graft is needed to cover the defect. This maneuver can also damage the graft during the delivery due to excessive force used or needed during the delivery process. Some surgeons also elect to place multiple sutures within the periphery of the graft for transfascial securement. This is often done prior to introduction of the graft. Once delivered into the abdominal cavity, the rolled graft/suture combination is unrolled, sutures isolated into respective corresponding abdominal quadrants, and the graft is centered over the defect prior to fixation. These steps are often very challenging and frustrating to accomplish in an efficient manner due to the pliable property of the graft and sutures which is a desired characteristic.
In addition, due to the change in concavity of the inner abdominal wall within versus the outer skin surface, correct sizing of the mesh or graft is compromised. This situation leads to an overestimation of the needed mesh or graft size, leading to further difficulties. These shortcomings contribute to a reason that laparoscopic methods, despite advantages, are less commonly utilized by many surgeons at the present time.
There is a need for a device and method that overcomes the deficiencies of current endoscopic or laparoscopic procedures, such as those used for ventral hernia repair. This new surgical device allows precise yet effortless delivery of a larger prosthetic mesh or graft via a novel trocar design for subsequent graft fixation. It also allows for more precise sizing of the defect thus eliminating a major frustration often encountered when working with a large piece of mesh or graft.